Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study
- Conditions
- MalnutritionNutrition Disorders
- Registration Number
- NCT05433831
- Lead Sponsor
- K Access Health Projects
- Brief Summary
Disease-related malnutrition (DRM) can occur when there is a deficient supply of energy, protein and/or other nutrients, depending on the nutritional needs of each individual at different times of their life cycle or health or disease circumstances. This deficiency induces effects on body composition and tissue and organ function and results in clinical consequences: increased morbidity and mortality associated with different disease processes.
There are techniques for nutritional assessment using assessment tools aimed at morphofunctional diagnosis of malnutrition, in addition to the classical nutritional parameters, such as weight loss, BMI, folds, circumferences, albumin, lymphocytes, cholesterol and intake. New advanced parameters are being incorporated into clinical nutrition and their incorporation into clinical practice is of increasing interest, such as measures derived from bioelectrical impedance (BIA) and phase angle (PhA), dynamometry, functional tests, CRP/prealbumin ratio and muscle ultrasound.
In 2019, the GLIM criteria were published, providing a different vision of how to assess the malnourished patient. Phenotypic criteria include reduction in muscle mass (measured using validated techniques to measure body composition).
The objective of the study is to highlight nutritional ultrasound for measuring muscle and functional status in order to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in this type of patients.
- Detailed Description
Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Patients admitted to hospital who in the first week of admission have moderate or high risk of malnutrition according to the MUST and SARC-F screening test using R-MAPP. Appendix
- Patient aged 18 to 85 years.
- Patient who agrees to participate in the study and signs the informed consent.
- Hepatic impairment (AST/ALT 3 x upper limit of normal)
- Chronic kidney failure (GFR <45 mL/min)
- Patient with previous ICU stay during the study admission.
- Cancer patients on palliative treatment or ECOG (Eastern Cooperative Oncology Group) ≥ 3.
- Orthopaedic disease that does not allow adequate walking
- Patients with known dementia or others not related to a significant neurological or psychiatric disorder, or any other psychological condition that may interfere with the conduct of the study.
- Patients with eating disorders
- Life expectancy of less than 6 months.
- Patients unable to adequately complete the clinical laboratory assessments required for the study protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe. Patients will be followed over a period of 6 consecutive months * Abdominal ultrasound: total, superficial and pre-peritoneal adipose tissue (measured in centimetres).
* Muscle ultrasound: Area, circumference, axes and adipose tissue (measured in centimetres)
- Secondary Outcome Measures
Name Time Method Subjective Global Assessment (SGA) Patients will be followed over a period of 6 consecutive months SGA questionnaire. SGA rank indicates the patient's nutritional status according to 3 categories: (1) well nourished, (2) moderate or suspected malnutrition, and (3) severe malnutrition.
Anthropometric data: Patients will be followed over a period of 6 consecutive months Arm circumference
Blood biochemistry data (at baseline visit, at 3 and 6 months): Patients will be followed over a period of 6 consecutive months lymphocytes
Functional parameters: Patients will be followed over a period of 6 consecutive months Dynamometry. Three measurements of the dominant hand will be made recording the mean and maximum, measured in kilograms. Jamar® dynamometers are most used in international studies and have several grip positions.
Sociodemographic data: Patients will be followed over a period of 6 consecutive months Risk of sarcopenia and moderate to high malnutrition based on MUST and SARC-F screening test using R-MAPP.
Bioelectrical impedance data (model (50 kHz): Patients will be followed over a period of 6 consecutive months % body fat
Current patient status: Patients will be followed over a period of 6 consecutive months Hospital stay, mortality at 3 and 6 months, hospital readmissions and complications. The complications occurring and their consequences (resolved/unresolved) must be recorded in the form.
Adherence. Patients will be followed over a period of 6 consecutive months Attendance to study follow-up visits.
Trial Locations
- Locations (25)
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.
🇪🇸Valladolid, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Spain
Hospital Universitario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga
🇪🇸Málaga, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Complejo Hospitalario Uni. Insular - Materno Infantil
🇪🇸Las Palmas De Gran Canaria, Spain
UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.
🇪🇸Málaga, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz De Tenerife, Spain
Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.
🇪🇸A Coruña, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain